Ascletis and Alphamab Announce Strategic Collaboration and Licensing Agreement for Anti-PD-L1 to Treat Hepatitis B and Other Viral Diseases

Ascletis Pharma Inc. (Ascletis, 1672.HK) and Suzhou Alphamab Co., Ltd. (Alphamab) jointly announce today that Ascletis’ subsidiary and Alphamab have entered into a strategic collaboration and exclusive licensing agreement for anti-PD-L1 KN035 to treat hepatitis B and other viral diseases in Greater China (Ascletis code: ASC22). KN035 is an investigational programmed cell death ligand-1 (PD-L1) monoclonal antibody which has been exposed to more than 500 patients in multiple clinical trials in US, China and Japan.

Under the terms of the agreement, Ascletis has an exclusive license from Alphamab to develop and commercialize ASC22 (KN035) for viral diseases including hepatitis B in Greater China. Ascletis will pay Alphamab a cash upfront payment and Alphamab will be eligible to receive payments in development and commercial milestones as well as tiered royalties from the mid-teens to around twenty percent on future sales of ASC22 (KN035). Alphamab will manufacture ASC22 (KN035) for clinical trials and commercialization of viral indications in Greater China for Ascletis. For ASC22 (KN035) in viral indications worldwide outside Greater China, Ascletis will be eligible to share certain economics such as upfront, milestone payments and royalties, depending on the development and regulatory status of ASC22 (KN035) inside Greater China.

Professor Guiqiang Wang, MD, President of Infectious Diseases Society of China, Vice-President of Chinese Society of Physicians for Infectious Diseases and Director of Centre for Liver Diseases at Peking University First Hospital, commented, «There is a lack of new innovative drugs that can lead to effective clinical cures for chronic Hepatitis B. As T cell exhaustion in HBV infections is an important factor in immune tolerance, blocking the PD-1/PD-L1 pathway could be an effective immunotherapy approach to improve specific T cell function and lead to a clinical cure for chronic Hepatitis B. PD-L1 antibody KN035 has been investigated in several global clinical trials in cancer patients, including pivotal cancer trials in China. These clinical trials provided invaluable human safety data for KN035. The subcutaneous route of administration for PD-L1 antibody ASC22 (KN035) provides a differentiated approach, which can increase patient compliance in clinical practice. I am very pleased that innovative Chinese biotechs are taking the lead in clinical studies of PD-L1 antibody for chronic Hepatitis B. Immunotherapy with PD-L1 antibody approach may lead to a significant breakthrough towards a clinical cure for chronic Hepatitis B.»

Jinzi J. Wu, PhD, Founder, Chairman and CEO at Ascletis said, «Alphamab is a leading biopharmaceutical company and we’re excited to partner with them. Hepatitis B remains a highly unmet medical need in China and globally. Through the strategic collaboration with Alphamab, we have the opportunity to develop ASC22 (KN035) as a potential first-in-class HBV immunotherapy and offer a clinical cure for Hepatitis B patients. Following the recent collaboration with Roche on Pegasys, this collaboration marks another major step forward for Ascletis to expand its pipeline and platform with biological drugs and to fulfill its commitment to developing innovative Hepatitis B therapies.»

«We are pleased to enter this strategic collaboration with Ascletis, a pioneer in innovative antiviral drug development,» said Dr. Ting Xu, Chairman of Alphamab. «Alphamab has been working on HBV for several years, we are excited to see KN035 to move into clinical development for Hepatitis B. With Ascletis’ demonstrated clinical development expertise in liver infectious diseases, we are confident that KN035 immunotherapy may lead to an effective clinical cure for Hepatitis B. With KN035 collaboration as a good starting point, Alphamab is looking forward to a much broader and long-term partnership with Ascletis in viral and liver diseases.

About KN035

KN035, as a PD-L1 single domain antibody Fc fusion, has the advantages of subcutaneous injection and good stability at room temperature. These would be of great value to improve patients’ compliance and quality of life and to help realize the goal of long-term management of cancer as a chronic disease.

With the close collaboration between Alphamab (together with its affiliate Jiangsu Alphamab Biopharmaceuticals Co., Ltd.) and 3D Medicines (Beijing) Co., Ltd, to date, KN035 has been studied in multiple clinical trials with more than 500 patients exposed in U.S, China and Japan. KN035 has entered into two pivotal trials and demonstrated good safety profile and encouraging preliminary efficacy.

About Ascletis

Ascletis is a China-based leading biotech company listed on Hong Kong Stock Exchange (Ascletis, 1672.HK). Ascletis’ mission is to become a world-class biotechnology company addressing unmet medical needs in three therapeutic areas: anti-viral, cancer and fatty liver disease. Led by a management team with deep expertise and a proven track record, Ascletis have developed an integrated anti-viral platform covering the entire value chain from discovery and development to manufacturing and commercialization. Ascletis is now promoting two promising drugs, Ganovo® (Danoprevir), the first direct acting anti-viral agent for HCV developed domestically and Pegasys® (Peginterferon alfa-2a), a well-established pegylated interferon for viral Hepatitis B&C partnered with Roche. For more information, please visit www.ascletis.com.

About Alphamab

Suzhou Alphamab Co., Ltd., focused on research and development of mAbs, fusion proteins and other biological macromolecule drugs. With multiple proprietary platforms in antibody screening, protein engineering, CMC development and pilot production set up in its 6000m2laboratory in Biobay Suzhou, Alphamab has created a robust pipeline of over 20+ novel biologics. Alphamab aims to develop affordable and efficient biological drugs to address high unmet medical needs globally.